{"active_ingredient":["Active ingredients(in each Softgel) Acetaminophen USP 325 mg Dextromethorphan HBr USP 15 mg Doxylamine succinate USP 6.25 mg"],"ask_doctor":["Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin"],"do_not_use":["Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product."],"dosage_and_administration":["Directions take only as directed do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over 2 softgels with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use"],"dosage_and_administration_table":["
adults & children 12 yrs & over2 softgels with water every 6 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use
"],"effective_time":"20260128","id":"47c7c8ae-62c2-383d-e063-6294a90a15fe","inactive_ingredient":["Inactive ingredients D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, sorbitol sorbitan solution, water"],"indications_and_usage":["Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing"],"keep_out_of_reach_of_children":["Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M012"],"brand_name":["Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["Softgel Healthcare Private Limited"],"package_ndc":["35916-0154-1"],"product_ndc":["35916-0154"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1094549"],"spl_id":["47c7c8ae-62c2-383d-e063-6294a90a15fe"],"spl_set_id":["229d1939-84a9-f18e-e063-6394a90aba30"],"substance_name":["ACETAMINOPHEN","DOXYLAMINE SUCCINATE","DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["362O9ITL9D","V9BI9B5YI2","9D2RTI9KYH"],"upc":["0335916015412"]},"other_safety_information":["Other information store at no greater than 25ºC"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC Code: 35916-0154-1 *Compared to the active ingredient in VICKS ® NyQuil TM Cold & F Liquicaps TM Acetaminophen 325 mg, Dextromethorphan Hbr 15 mg and Doxylamine Succinate 6.25 mg Softgelatin Capsules Fever, Sore Throat, Headache, Minor Aches & Pains Runny Nose & Sneezing Cough Night time (Cold & Flu - 12 Softgels) Night time Cold and Flu"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding ask a health professional before use."],"purpose":["Purpose Pain reliever/Fever reducer Cough suppressant Antihistamine"],"set_id":"229d1939-84a9-f18e-e063-6394a90aba30","spl_product_data_elements":["Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate GLYCERIN SORBITOL WATER GELATIN POVIDONE POLYETHYLENE GLYCOL 400 ACETAMINOPHEN ACETAMINOPHEN D&C YELLOW NO. 10 PROPYLENE GLYCOL DOXYLAMINE SUCCINATE DOXYLAMINE FD&C BLUE NO. 1 DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN Oblong square transparent"],"spl_unclassified_section":["TAMPER EVIDENT This package is safety-sealed. Use only if blisters are intact. If difficult to open, use scissors.","Manufactured by Softgel Healthcare Pvt Ltd., Survey no. 20/1, Vandalur-Kelambakkam Road, Pudupakkam Village, Kancheepuram District, Tamilnadu – 603103, India Mfg. Lic. No: xxxxxxxxxxxxxx"],"stop_use":["Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition."],"version":"2","warnings":["Warnings Liver warning: This product contains acetaminophen.Severe liver damage may occur if you take more than 8 softgels in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away Sore throat warning: If sore throat is severe, persists for more than 2 days,is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly."],"when_using":["When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, & tranquilizers may increase drowsiness"]}